Table 2. Primary Outcome.
| Outcome/analysisa | Fixed-dose hydrocortisone (n = 137) | Shock-dependent hydrocortisone (n = 141) | No hydrocortisone (n = 101) |
|---|---|---|---|
| Primary outcome, organ support–free days | |||
| Median (IQR) | 0 (–1 to 15) | 0 (–1 to 13) | 0 (–1 to 11) |
| Subcomponents of organ support–free days | |||
| In-hospital deaths, No. (%) | 41 (30) | 37 (26) | 33 (33) |
| Organ support–free days among survivors, median (IQR) | 11.5 (0 to 17) | 9.5 (0 to 16) | 6 (0 to 12) |
| Primary analysis of the primary outcome, using covariate data from all severe-state participants with COVID-19 (n = 576)b | |||
| Adjusted odds ratio | |||
| Mean (SD) | 1.47 (0.35) | 1.26 (0.31) | 1 [Reference] |
| Median (95% CrI) | 1.43 (0.91 to 2.27) | 1.22 (0.76 to 1.94) | 1 [Reference] |
| Probability of superiority to no hydrocortisone, % | 93 | 80 | |
| Secondary analysis of the primary outcome, restricted to corticosteroid domain participants (n = 379) with no adjustment for intervention assignment in other domainsc | |||
| Adjusted odds ratio | |||
| Mean (SD) | 1.49 (0.35) | 1.28 (0.30) | 1 [Reference] |
| Median (95% CrI) | 1.45 (0.93 to 2.30) | 1.24 (0.80 to 1.95) | 1 [Reference] |
| Probability of superiority to no hydrocortisone, % | 95 | 83 | |
Abbreviations: COVID-19, coronavirus disease 2019; IQR, interquartile range; CrI, credible interval.
Definitions of organ support–free days and other outcomes are provided in the Methods section and the study protocol (Supplement 1). Models are structured such that a higher odds ratio is favorable. Other sensitivity analyses are described in the Results section and provided in eTables 1 and 2 and eAppendices 3 and 4 in Supplement 2.
The primary analysis used data from all participants enrolled in the trial who met COVID-19 severe state criteria and were randomized within at least 1 domain (n = 576), adjusting for age, sex, time period, site, region, domain and intervention eligibility, and intervention assignment (see COVID-19 Corticosteroid Domain statistical analysis plan in Supplement 1 and full report from the statistical analysis committee in eAppendix 3 in Supplement 2).
The secondary analysis was restricted to participants enrolled in the corticosteroid domain (n = 379) and did not include information on assignment to interventions other than hydrocortisone.